MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. CRITICORE® FOLEY TRAY BARDEX® TEMPERATURE-SENSING FOLEY CATHETER

Model Number	901216
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that hair was found in the syringe.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Set-up procedure: hang the monitor on the bedframe near the foot of the bed ensuring that the unit hangs freely, or set on the floor in a safe location.Using proper aseptic methods, open csr wrap to form sterile field and expose catheterization kit.Prepare patient for catheterization using standard technique.Insert catheter using standard technique.Inflate the catheter with the syringe provided.Instill entire amount of sterile water (10cc).Note: if using syringe other than that provided, use luer tip syringe, 10cc maximum.Do not use needle.Turn the monitor on by pressing the "on/off" switch (1).Lift the top of the monitor (14) and place the container securely in the monitor.Lower the lid ensuring that it closes completely and that it traps the container within the monitor.If the monitor is not being used, hang the fluid collection container on the bed using the attached string and hook.Plug the end of the temperature-sensing catheter's extension cable into the connector jack (13) on the side of the monitor.For convenience, the extension cable may be threaded through the sheeting clips.Ensure that the tubing extends from the fluid collection container in a smooth, unkinked path and that no part of the tubing hangs below the top of the container.Note: if it is desired to record the initial in-rush volume of fluid in the "present interval output" display first turn the monitor on, place the empty container in the monitor, and then allow the fluid to flow into the container.The slide clamp on the collection container tubing may be used for this purpose.Catheter should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation,or any other catheter-related adverse effect, the catheter should be replaced.To drain the container: empty any fluid in tubing into collection container.Wait until this volume registers in the "present interval output" display (6).Close slide clamp.Drain container.Reopen slide clamp.Directions for using bard ez-lok sampling port: bard ez-lok sampling port accepts a luer-lock or slip tip syringe.Kink drainage tubing a minimum of 3 inches below the sample port until urine is visible under access site.Swab surface of access site with antiseptic wipe.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sample port.Periodic observation of the sampling port is recommended.Aspirate desired volume of urine.Unkink tubing and send specimen to laboratory.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." (b)(4).The device was not returned.
Event or Problem Description
It was reported that hair was found in the syringe.

• Brand Name: BARDEX® I.C. CRITICORE® FOLEY TRAY BARDEX® TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7034081
• Report Number: 1018233-2017-05922
• Device Sequence Number: 977376
• Product Code: MJC
• UDI-Device Identifier: 00801741019562
• UDI-Public: (01)00801741019562
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 901216
• Device Catalogue Number: 901216
• Device Lot Number: NGBS2131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1